Endoscopic Bariatric Therapies (EBTs): A Retrospective and Prospective Multicenter Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 9,999
- 试验地点
- 1
- 主要终点
- Safety of procedure measured by in the number of adverse events of procedure
研究概览
简要总结
The purpose of this registry study is to collect data through medical chart review and in patient visits on the efficacy and safety of various Endoscopic Bariatric therapies (EBTs). This is a retrospective and prospective, observational, medical chart review study for at least 6 standard of care visits up to 1 years after a subject consents for study participation.
详细描述
Endoscopic bariatric therapies such as intragastric balloons, space occupying EBTs, endoscopic sleeve gastroplasty (ESG), primary obesity surgery endolumenal (POSE), and small bowel interventions including gastrointestinal bypass sleeves, etc. are recommended alone or in conjunction with other weight loss treatment modules for patients who cannot or do not want to undergo conventional bariatric surgery or other therapies for obesity (with BMI ≥30 kg/m2) or BMI >27 with comorbidities.
This research is being done in order to find out if endoscopic bariatric therapies work as well as, or better or worse than, other currently available treatment modules to achieve weight loss.
The study is to create a registry to analyze a longitudinal observational cohort of patients who have undergone endobariatric procedures. We will collect information through standard of practice visits and through chart review.
Laboratory data, patient characteristics, imaging, histology will be collected. In certain patients - after specific consent extra blood may be collected for research purposes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient who is considering undergoing EBT for weight loss within 6 months, or has undergone clinically indicated EBT for weight loss within the past 6 months
- •Above or equal to 18 years of age.
排除标准
- •Any patient who has not undergone or will undergo EBT for weight loss
- •Below 18 years of age.
结局指标
主要结局
Safety of procedure measured by in the number of adverse events of procedure
时间窗: at baseline
Number of adverse events; Type (unexpected, expected, related, possibly related), frequency and intensity of adverse events at baseline
Change of weight of the various bariatric therapies
时间窗: Baseline, 1 month, 6 months, and 1 year post procedure
Compare mean percentage total body weight loss achieved via various Endoscopic Bariatric Therapies compared to baseline, 1 month, 6 months and 1 . year post procedure. This will be calculated by measuring the patients weight on a scale and comparing it to their baseline weight pre procedure.
Safety of procedure measured by in the number of adverse events that occur within 30 days
时间窗: Within 30 days of the procedure
Number of adverse events; Type (unexpected, expected, related, possibly related)
次要结局
- Technical success of each bariatric therapy.(through study completion at one year.)
- Change in the effect of Endoscopic Bariatric Therapies on reflux(Baseline, 6 months,and 1 year post procedure)
- Change and Improvement in comorbidities(6 months, 1 year post procedure)
- Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease(Baseline, 6 months,and 1 year post procedure)